What are the responsibilities and job description for the Director, Nonclinical Safety position at Omega Therapeutics?
About Omega Therapeutics:
Omega Therapeutics is a publicly held, development-stage biotechnology company pioneering a new class of DNA-sequence-targeting, mRNA-encoded therapeutics to transform human medicine. The OMEGA Epigenomic Programming™ platform harnesses the power of epigenetics, the mechanism that systematically controls every aspect of an organism’s life from cell genesis, to growth and differentiation. The OMEGA platform has identified thousands of novel DNA-sequence-based epigenomic targets within Insulated Genomic Domains (IGDs), referred to as EpiZips™. IGDs represent the three-dimensional, distinct, and evolutionarily conserved architecture of the genome, and are the fundamental structural and functional units of gene control and cell differentiation. They act as the “control room” of biology. The OMEGA platform examines alterations in IGDs leading to aberrant gene expression, a cause of most disease. It then leverages its database of EpiZips to identify appropriate intervention points within the IGDs and rationally designs biologically engineered, modular, and programmable mRNA-encoded epigenetic medicines, called Omega Epigenomic Controllers™, to target EpiZips for Precision Genomic Control™. With its computation- and data-first approach, Omega Therapeutics is currently advancing a broad pipeline of programs that span regenerative medicine, multigenic diseases including immunology, oncology, and select monogenic diseases.
Omega Therapeutics was founded by Flagship Pioneering in 2017. For more information, visit omegatherapeutics.com,
About the Role:
Omega Therapeutics, Inc. is seeking a Director, Nonclinical Safety (commensurate with experience) to join our Discovery Research & Early Development team to design a nonclinical development plan and ensure the execution of nonclinical toxicology and safety studies. They will oversee the design and management of safety pharmacology and toxicology studies (GLP and non-GLP) supporting preclinical and clinical development programs. They must be a scientifically motivated self-starter, capable of working with minimal supervision, and conducting and critically analyzing experiments. They will collaborate with senior project scientists and other stakeholders to meet aggressive timelines.
We are looking for enthusiastic, detail oriented and highly motivated individuals with a passion for bringing novel medicines to patients and who are comfortable working on a fast-paced scientific team.
Key Responsibilities:
- Support the department’s leadership team in both the strategic vision for the department and in the efficient and progressive running of the department
- Lead overall scientific, technical, and operational efforts supporting DMPK across the project portfolio
- Provide scientific guidance on development candidate selection; work in close collaboration with colleagues to optimize and evaluate the DMPK properties of candidates
- Define appropriate strategies, design internal/external DMPK studies and be responsible for oversight and deliverables from external studies
- Work closely with the therapeutic development teams to evaluate the biodistribution and safety of Omega OECs
- Work with project teams to plan, coordinate, and execute in vitro and in vivo safety assessments including in-vivo studies with contract research organizations
- Establish state of the art methods for quantifying drug levels in various biological matrices
- Build a team to support early development activities at Omega, provide mentorship and well as expert advice and context for the interpretation of complex data
Required Skills:
- Ph.D. scientist in a relevant field; a proven scientific leader with 10 years of industry experience in pharmacology/DMPK
- Experience conducting discovery and IND enabling nonclinical studies in multiple species
- Prior contributions to assembling pharmacology/DMPK sections of regulatory documents (IND/CTA)
- Outstanding teamwork, communication, and interpersonal skills
- Team leadership experience with a demonstrated track record of personnel development
- Therapeutic expertise in oncology, immunologically-based diseases highly desirable
- Track record of successful problem solving, high quality science and influencing of stakeholders, particularly in a drug project context